Status:
COMPLETED
Glucose Tolerance in Healthy Overweight Adults
Lead Sponsor:
Abbott Nutrition
Conditions:
Overweight
Eligibility:
All Genders
20-45 years
Phase:
PHASE2
Brief Summary
The primary objective is to compare the postprandial glycemic response of healthy overweight adults after consuming an amino acid drink mix versus a control drink.
Eligibility Criteria
Inclusion
- Fasting blood glucose level of ≥ 70mg/dL and ≤ 125 mg/dL.
- Subject states that he/she does not have type 1 or 2 diabetes.
- Subject is overweight as defined as waist circumference ≥ 101 cm (40 inches) male; ≥ 88 cm (35 inches) female.
- Subject's BMI is ≥ 25 kg/m2.
- Subject's blood pressure is \< 140 mm Hg systolic and \< 90 mm Hg diastolic.
- Subject is between 20 and 45 years of age, inclusive.
- Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
- If female is of childbearing potential, is practicing birth control
- If subject is on a chronic medication such as a thyroid medication or hormone therapy, has been on constant dosage for at least two months prior to screening visit.
Exclusion
- Subject is eating a low carbohydrate diet such as Atkins, Zone, or South Beach diet plan.
- Subject states that he/she has current infection, has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit.
- Subject states that he/she has an active malignancy.
- Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
- Subject states that he/she has end-stage organ failure or is status post organ transplant.
- Subject states that he/she has a history of renal disease.
- Subject states that he/she has current hepatic disease.
- Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- Subject has taken/is currently taking any herbals, dietary supplements, or medications during the past four weeks prior to screening visit that could profoundly affect blood glucose.
- Subject has taken/is currently taking any herbals, dietary supplements, or medications during the past four weeks prior to screening visit to control hypertension or cholesterol.
- Subject states that he/she has clotting or bleeding disorders.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00974831
Start Date
July 1 2009
End Date
October 1 2009
Last Update
November 25 2010
Active Locations (1)
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1
University of Texas
Austin, Texas, United States, 78712